Status:
COMPLETED
Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a multiple dose, observer blind, randomised, parallel groups pharmacodynamic and pharmacokinetic study to assess the endometrial effects (predecidual changes) of a new aqueous progesterone for...
Detailed Description
This study is designed in order to assess the efficacy of the investigational product (Progesterone acqueous s.c. formulation) when it is administered at the dose of 25 and 50 mg. The induced predecid...
Eligibility Criteria
Inclusion
- BMI: 19\</=BMI\</=25 kg/m2;
- Proper estrogen priming; absence of progesterone exposure prior to exogenous progesterone administration;
- normal pelvic ultrasound;
- absence of active follicular growth following initiation of E2 treatment;
- Complete suppression of ovarian function;
- Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm;
- Full comprehension of the nature and purpose of the study and possible risks and side effects;
- signed written informed consent prior to inclusion in the study
Exclusion
- pregnant or lactating women;
- ECG: clinically relevant abnormalities;
- clinical relevant abnormal physical findings which could interfere with the objectives of the study;
- clinical relevant abnormal laboratory values indicative of physical illness, ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;
- history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
- history of uterine pathologies (fibroids, polyps, adenomyosis, etc), history of dysfunctional bleeding, relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, history of neoplasias (genital apparatus, breast, liver or hormone-dependent cancer) severe liver failure, acute or chronic liver dysfunction, cholestatic jaundice, hypertension, thrombo-phlebitis, thrombo-embolism, cerebro-vascular insult or severe depression; medication, including OTC, during 2 weeks before the start of the study;
- participation in the evaluation of any drug within 1 month prior to the start of the study;
- blood donations during the 1 month prior to this study;
- history of drug, alcohol \[\>1 drink/day defined according to USDA Dietary Guidelines 2005 (18)\] caffeine (\>5 cups/ day of coffee or tea) or tobacco abuse (≥10 cigarettes/day);
- Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00377923
Start Date
August 1 2005
End Date
March 1 2006
Last Update
September 20 2006
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